FDA drug approvals: Makary and Prasad say one study will be enough
FDA Shifts Gears: One Trial Enough for New Drug Approvals? The Food and Drug Administration is poised to dramatically alter its drug approval process, moving away from a decades-traditional standard of requiring two rigorous clinical trials. This shift, spearheaded by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, aims to accelerate the availability of … Read more